SCIENTIST/SENIOR SCIENTIST, ANALYTICAL TECHNOLOGIES

Analytical Development Pleasanton, CA


Description

Position Summary:

The Scientist/ Sr. Scientist will be a leading member in the Analytical Technologies group responsible for bioassay development, validation, transfer and execution at Gritstone Bio. The bioassays includes cell-based potency assay, ELISA, PCR-based assays, and virus infectivity assays, etc., that are used to support product characterization, release, stability study in GMP setting as well as other research projects for process, formulation and manufacturing development. This position will contribute to the strategy of selecting and implementing bioassays to ensure our products are comprehensively characterized and under superb quality control. With dedication to trouble-shooting and optimizing assays on bench, this position may lead a small group to achieve department goals. Excellent training and background in biological sciences, such as cell biology, molecular biology, biochemistry, immunology, virology, etc., is required. Biologics experience is preferred but not a must-have.

Responsibilities:

  • Independently select, develop, validate, and transfer biological assays including cell-based potency assays, ELIZA, qPCR-based assays, virus infectivity assays, etc.
  • Justify in front of a review panel that the bioassays are suitable for the intended use per appropriate regulatory guidelines
  • Evaluate new technologies and innovate bioassays to expand analytical capabilities of the group
  • Working knowledge of compliance requirements for bioassay development and validation as in guidelines published by FDA, ICH, EMA, USP, etc.
  • Working knowledge of GMP production of biologics including proteins, cell and gene therapy and relevant requirements of analytical methods used for GMP production of biologics
  • Experience in virus-vector based biotechnology or virology in general is preferred but not required
  • Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release and stability testing of drug substance and drug products
  • Author method SOPs, development reports, qualification/validation reports to support method transfer to GMP QC
  • Trouble-shoot and optimize bioassays with hands-on work on bench
  • Manage analytical method development, qualification, validation, and transfer at CRO/CMO sites
  • Manage other CMC activities at CRO/CMO sites where Analytical Technologies group is involved
  • Represent the Analytical Technologies group in meetings with collaborators to help with the interpretation of data, selection of test methods, resource allocation and priority setting, etc
  • Train junior staff members
  • Other duties as assigned
Qualifications:
  • 10+ years of industry experience with a BS Degree in a relevant scientific discipline or 5+ years of industry experience with a Ph.D. degree
  • Experience in developing and validating biological assays in the pharmaceutical or biotech industry is essential. Experience with biologics is preferred.
  • Sound understanding and adequate skills in statistics
  • Excellent written and oral communication skills
  • Outstanding attention to detail
  • Ability to work independently and on teams
  • Strong time management skills
  • Personnel management and project management experience is preferred but not required